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CompletedNCT034017233D-CoPSUpdated Apr 11, 2018

A Validation Study of a Computerized Movement Analysis of the Colonoscope in Simulated Colonoscopy

An interventional study of 3D-Colonoscopy Progression Score and Endoscopy Training System in Education, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

A cross validation study comparing an international acknowledged assessment tool "Endoscopy Training System" (ETS) and movement analysis of the colonoscope based on raw data from coils within the scope.

24 physicians are recruited and divided based on experience (novices and experienced). All participants are to perform twice on the ETS that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. The movement of the colonoscope will be gathered during the tasks and correlated to the scores of the ETS.

Read the detailed description

24 physicians are recruited on a voluntarily basis, and will be divided into two groups, based on experience;

  1. 12 Novices (0-50 colonoscopies)
  2. 12 Experienced (> 140 colonoscopies). The groups are to perform twice on the Endoscopy Training System that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. Data for 3D-Colonoscopy Retraction Score (3D-CoRS) will be gathered during the task of mucosal inspection and data for 3D-Colonoscopy Progression Score (3D-CoPS) are collected during loop management.

Novice group:

Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.

Experienced group:

Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists.

Demographic data will gathered from all three groups as follows:

  • Age
  • Sex
  • Speciality
  • Total number of colonoscopies
  • Total number of colonoscopies the last year
  • Time since graduation
  • Experience in simulated endoscopy/colonoscopy The Endoscopy Training System is a simulation system and an assessment tool and includes five different performance metrics and a scoring system. The system is used in combination with an Olympus colonoscope (Olympus Medical Systems Corp. Tokyo, Japan).

Performance metrics:

  1. Scope Manipulation (SM) - The use of torque and tip deflection to move a shape in the colon to the 6 o´clock position and align the same shape within an outline placed upon the monitor screen. Before continuing to the next shape, alignment must be held for 5 seconds.
  2. Tool Targeting (TT) - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched for at least 5 seconds before moving to the next target.
  3. Loop Management (LM) - The management of a standard alfa-loop. If during insertion from anus until cecum a loop is formed, it must be first recognised and then unlooped successfully to continue advancing the colonoscope.

    The Colonoscopy Training Model begin in the left lateral position, but on request, the model can be repositioned in the supine, prone, or right lateral decubitus position. On request, abdominal pressure can be provided when directed by the participant.

  4. Mucosal Inspection (MI) - Randomly placed polyps inside the rubber colon have to be found during withdrawal, requiring inspection and retroflexion in the rectum.
  5. Retroflexion (RF) - 5 targets located around the anus must be found. With a biopsy forcep, each target has to been touched while the colonoscope is retroflexed in the rectum and touched for at least 5 seconds before moving to the next target.

The 3D-Colonoscopy Progression Score (3D-CoPS) and the 3D-Colonoscopy Retraction Score (3D-CoRS) are movement analysis. Electromagnetic coils are built in along the length of the Olympus colonoscopes. They generate a pulsed low-intensity magnetic field that is picked up a receiver coil. The data-points for each coil are inserted into an algorithm for movement analyzing. This analysis is done as a change between the tip of the scope, and the next tracked magnetic coil. The result is a relative movement of the colonoscope in relation to the previous position, and how much the movement is deflected according to the direction the tip points in. This movement analysis is used for distinction between the progression- and retraction phase, and as the basis for the 3D-CoPS and 3D-CoRS analysis, which is essential, such that the 3D-CoRS measurements is performed during withdrawal of the colonoscope.

02

Conditions studied

  • Education

Keywords

  • Validation study
  • Simulation
  • Endoscopy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Physicians

Exclusion criteria

Exclusion Criteria:

  • Non physicians
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    Novices

    Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies. Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.

    Other: 3D-Colonoscopy Progression Score · Other: Endoscopy Training System · Other: 3D-Colonoscopy Retraction Score

  • Other
    Experienced

    Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists. Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.

    Other: 3D-Colonoscopy Progression Score · Other: Endoscopy Training System · Other: 3D-Colonoscopy Retraction Score

Interventions

  • Other3D-Colonoscopy Progression Score

    3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.

    Also known as: 3D-CoPS

  • OtherEndoscopy Training System

    The Endoscopy Training System is based on the Colonoscopy Training Model platform and includes four different performance metrics and a scoring system. 1. Scope Manipulation - The use of torque and tip deflection to move a shape in the colon 2. Tool Targeting - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched. 3. Loop Management - The management of a standard alfa-loop. 4. Mucosal Inspection - Randomly placed polyps inside the rubber colon have to be found during withdrawal.

    Also known as: ETS

  • Other3D-Colonoscopy Retraction Score

    3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.

    Also known as: 3D-CoRS

05

What researchers measure

Primary outcomes

  1. 3D-Colonoscopy Progression Score

    The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000 .A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.

    Time frame: 3 months

  2. 3D-Colonoscopy Retraction Score

    The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.

    Time frame: 3 months

Secondary outcomes

  1. Relationship to other variables

    Scores from the ETS, 3D-CoPS and 3D-CoRS will be correlated.

    Time frame: 3 months

06

Study locations

1 site
  • Copenhagen Acedemy of Medical Education and Simulation
    Copenhagen, 2100, Denmark
07

References and documents

Publications

  • Ritter EM, Cox TC, Trinca KD, Pearl JP. Simulated Colonoscopy Objective Performance Evaluation (SCOPE): a non-computer-based tool for assessment of endoscopic skills. Surg Endosc. 2013 Nov;27(11):4073-80. doi: 10.1007/s00464-013-3063-8. Epub 2013 Jul 17. PubMed 23860607 ↗
  • Trinca KD, Cox TC, Pearl JP, Ritter EM. Validity evidence for the Simulated Colonoscopy Objective Performance Evaluation scoring system. Am J Surg. 2014 Feb;207(2):218-25. doi: 10.1016/j.amjsurg.2013.08.026. Epub 2013 Oct 23. PubMed 24246259 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03401723
Lead sponsor
Rigshospitalet, Denmark
Collaborators
Technical University of Denmark
Responsible party
Andreas Slot Vilmann (MD. Andreas Slot Vilmann, Rigshospitalet, Denmark) — Principal investigator
First posted
Jan 17, 2018
Start date
Dec 1, 2017
Primary completion
Mar 21, 2018
Completion
Mar 30, 2018
Last update
Apr 11, 2018

Study contacts

Lars Konge, Prof
study director · CAMES-Rigshospitalet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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